THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
FDA premarket approval P060040/S039 · decided 2015-03-24
Approval details
- PMA number
- P060040
- Supplement
- S039
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2015-02-23
- Decision date
- 2015-03-24
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- ALTERNATE METHOD FOR THE MOLDING PROCESS OF THE HEARTMATE II PERCUTANEOUS CABLES.
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